• Amgen Inc., of Thousand Oaks, Calif., said data showed Sensipar effectively reduces parathyroid hormone levels in patients on dialysis with secondary hyperparathyroidism and lowers elevated calcium and phosphorus levels. The data were published in this week's issue of the New England Journal of Medicine. A total of 741 chronic kidney disease patients participated in the two studies in which 43 percent of patients in the Sensipar group achieved the primary endpoint, as compared to 5 percent of patients in the placebo group.

• Amylin Pharmaceuticals Inc., of San Diego, signed an agreement to co-promote Liberty Corners, N.J.-based Reliant Pharmaceuticals LLC's cardiovascular products that address cholesterol management and hypertension to a target group of endocrinologists in the U.S. The agreement allows Amylin to benefit from its sales staff experience, while it focuses on the potential commercialization of its diabetes compounds. Amylin will help promote the Lescol, DynaCirc and InnoPran product families.

• BioMedicines Inc., of Emeryville, Calif., appointed Alice Leung president and CEO. Previously, Leung was vice president, general manager of the oncology business unit at Berlex Laboratories, the U.S. affiliate of Schering AG, of Berlin. BioMedicines is developing therapies for the treatment of cancer and infectious disease.

• Connetics Corp., of Palo Alto, Calif., said the FDA accepted for filing the company's new drug application for Extina. The user-fee goal date for the drug is Sept. 24. Extina is a formulation of 2 percent ketoconazole delivered in the company's VersaFoam delivery system as a treatment for seborrheic dermatitis.

• Embrex Inc., of Laurinburg, N.C., said it is opening a biological manufacturing facility. Known as Embrex Poultry Health, Embrex intends to use the Laurinburg facility to produce its Inovocox in ovo coccidiosis vaccine upon approval from the U.S. Department of Agriculture. The opening occurred March 30. Coccidiosis is a parasitic disease of the chicken's digestive system.

• Endovasc Inc., of Montgomery, Texas, said it plans to appeal the recent ruling in its lawsuit regarding stock manipulation against J.P. Turner & Co. LLC, in the U.S. District Court, Southern District of New York. Endovasc's CEO and President Diane Dottavio said the company "strongly" disagrees with the ruling of the judge in the case. Endovasc is developing two cardiovascular and metabolic drug therapies.

• Entropin Inc., of Indio, Calif., a development stage pharmaceutical company focused on the pain therapy market, is beginning to design the protocol for the human testing of its chemical entity, ENT-103. ENT-103 is designed to block nerve-impulse conduction.

• eXegenics Inc., of Dallas, named David Riggs president and CEO in addition to his position of chief financial officer. Riggs joined the company in March 2003 as vice president, chief business officer and chief financial officer. EXegenics previously operated as a small-molecule drug discovery company, but it discontinued all research and development programs last year. In December, the company's board established a committee to study strategic direction and identify business opportunities.

• Favrille Inc., of San Diego, filed for an initial public offering Thursday - just a few days after completing a $44 million Series C round financing. The company aims to raise $86.25 million in the IPO. The number of shares to be offered and the price range have not yet been determined. The company said in its prospectus that it would use net proceeds to prepare for the development and commercialization of its vaccine FavId to treat follicular B-cell non-Hodgkin's lymphoma. Remaining proceeds would be used for advancing other product candidates, expanding its manufacturing capabilities and general corporate purposes. About $8.2 million would be used to repay existing debt. Piper Jaffray & Co. is acting as lead manager, with Needham & Co. Inc., William Blair & Co. and First Albany Capital acting as co-managers. Since its inception in January 2000, the company has raised $77 million, including the $44 million raised earlier this week. The company's chief financial officer, Tamara Seymour, said earlier this week that the company had enough cash for two years. A Phase III study of FavId is expected to begin in the third quarter. (See BioWorld Today, April 8, 2004.)

• Gene Logic Inc., of Gaithersburg, Md., entered a multiyear agreement with the National Cancer Institute, Division of Cancer Treatment and Diagnosis in Bethesda, Md., to provide preclinical safety and pharmacology studies focused on NCI's core research areas of interest: cancer, AIDS and AIDS-related illnesses. The agreement provides for Gene Logic to achieve up to $6.9 million in revenue over the next seven years based on specific studies and services requested by the agency over the life of the agreement.

• GlycoFi Inc., of Lebanon, N.H., initiated a joint research study to evaluate its yeast-based platform for the production of an undisclosed protein. The study, supported by Eli Lilly and Co., of Indianapolis, will combine GlycoFi's expression technology to produce human glycoproteins with Lilly's expertise in the area of therapeutic protein discovery and commercialization.

• Gryphon Therapeutics Inc., of South San Francisco, said its technology for the construction of synthetic proteins is featured in the April issue of Scientific American. The item in the publication is devoted to Chemical Protein Synthesis, the technique Gryphon applies to the design and manufacture of its synthetic protein therapeutics. The company said the article discusses the history of the technology.

• Guava Technologies Inc., of Hayward, Calif., said using Guava Express and the Guava PCA cell-analysis system enables researchers to study cell migration and screen for drug compounds that affect that process. Guava collaborators have shown that use of Guava Express in an actin polymerization assay can provide an early measure of chemotaxis within seconds of exposure to stimuli.

• Immunomedics Inc., of Morris Plains, N.J., and Amgen Inc., of Thousand Oaks, Calif., said that Amgen returned to Immunomedics all rights for epratuzumab, the humanized CD22 monoclonal antibody therapeutic licensed to Amgen by Immunomedics in December 2000, including rights to second-generation molecules and conjugates. As part of the transaction, Immunomedics agreed to issue to Amgen a five-year warrant to purchase 100,000 shares of the company's common stock with a strike price equal to $16 per share. Amgen will receive a final payment of $600,000 from Immunomedics if epratuzumab is approved for commercialization in the U.S. for non-Hodgkin's lymphoma therapy.

• Metabasis Therapeutics Inc., of San Diego, received a milestone payment of $3.5 million from Sankyo Co. Ltd., of Tokyo, for the successful completion of a second Phase IIa trial of CS-917, its first-in-class oral gluconeogenesis inhibitor of the treatment of patients with Type II diabetes mellitus. The study was a 28-day trial involving 144 patients with Type II diabetes. The company said results provide evidence that the new class of drugs is capable of reducing blood glucose levels in diabetic patients.

• NeoPharm Inc., of Lake Forest, Ill., selected Diosynth Biotechnology, a unit of Akzo Nobel NV, of Arnhem, the Netherlands, to manufacture clinical quantities for a Phase III trial in malignant glioma. NeoPharm based its selection on the successful process development and early clinical manufacture of interleukin-13-PE38QQR, an experimental tumor-targeting cancer drug that is being investigated as a treatment for first recurrence of glioblastoma multiforme.

• Neurochem Inc., of Montreal, signed a conditional agreement to purchase Shire BioChem Inc.'s facilities located in Laval, Quebec, for C$10.5 million (US$7.9 million). Upon completion of the transaction, Neurochem will relocate its headquarters and staff. The transaction will be financed by asset-based funding and cash on hand. Neurochem is focused on the development and commercialization of therapeutics for neurological disorders.

• Odyssey Thera Inc., of San Ramon, Calif., reported an agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to carry out pilot studies aimed at profiling selected Roche compounds across Odyssey Thera's panels of cell-based assays in order to further characterize mechanism of action and pathway activity. Odyssey Thera probes the biochemical networks of living cells to identify on-pathway and off-pathway effects of drugs and lead compounds.

• Pharmacopeia Inc., of Princeton, N.J., said the proposed spinoff of its Pharmacopeia Drug Discovery Inc. (PDD) unit is expected to occur at the end of this month. The board intends to meet next week to consider final approval. Following Nasdaq approval, PDD stock would trade under the symbol "PCOP." Pharmacopeia will continue to trade under the "ACCL" symbol, and the company will change its name to Accelrys to better reflect its focus on the scientific software business. (See BioWorld Today, Dec. 22, 2003.)

• Pharmacyclics Inc., of Sunnyvale, Calif., closed a public offering of 3.2 million shares of common stock, raising net proceeds of about $39.6 million. The shares were sold at $13 each. Pacific Growth Equities LLC acted as the sole bookrunning manager and underwriter of the offering, which included the exercise of the overallotment option. (See BioWorld Today, April 5, 2004.)

• Pro-Pharmaceuticals Inc., of Newton, Mass., raised about $4.5 million in gross proceeds from new and existing institutional investors through the private placement of about 1.25 million newly issued shares of common stock. Investors also will receive five-year warrants to purchase about 625,000 shares of common stock. Proceeds will be used to fund ongoing operations, including clinical trials and research and development. Rodman & Renshaw acted as the placement agent.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., launched a Phase II trial to evaluate elsamitrucin as a single-agent therapy for patients with refractory non-Hodgkin's lymphoma. The trial will enroll about 80 patients who have failed multiple prior therapies, including Rituxan (rituximab). Elsamitrucin is an antitumor antibiotic that acts as a dual inhibitor of two key enzymes involved in DNA replication, topoisomerase I and II.

• Vaso Active Pharmaceuticals Inc., of Danvers, Mass., said the company's stock will not trade again until April 16, while the SEC investigates questions regarding the accuracy of company assertions in press releases, its annual report and other public statements to investors. The company has said it will take whatever remedial action is necessary. A class-action lawsuit was filed against the company on Thursday with claims that officers and directors issued false and misleading statements concerning its core products, including its deFEET product. Vaso Active focuses on vaso active lipid encapsulated transdermal delivery technology drugs.

• Xtrana Inc., of Broomfield, Colo., said stockholders approved the sale of the company's intellectual property to the Applied Biosystems Group, of Foster City, Calif., for $4 million in cash. Applied Biosystems is purchasing all of Xtrana's IP, other than trademarks and trade names. The assets include all U.S. and foreign patents, inventions, trade secrets and know-how. The $4 million payment consists of $100,000 in cash as a deposit, $3.5 million in cash to be paid at closing and $400,000 in cash to be paid 90 days after closing.